The present invention relates to the field of non-traditional medicine, in particular to acupuncture, and more specifically, to an electro-acupuncture device.
Acupuncture is a form of traditional Chinese medicine that encourages the body to heal itself naturally. It is over 5,000 years old and considered one of the most beneficial ways of restoring balance to the body. Traditional Chinese medicine doctors believe that acupuncture revitalizes our qi, the energy force that flows through the body in pathways known as meridians. Through the painless insertion of very fine needles into specific acupuncture points along the meridians, acupuncture unblocks qi and makes us less susceptible to disease, infection and stress.
Western medicine explains acupuncture""s success differently. Some scientists link qi to endorphinsxe2x80x94natural pain-killing chemicalsxe2x80x94that are released in the needling process, while other scientists believe that acupuncture stimulates muscle tissue, which then alters the nervous system and allows the body to self-heal internal organs. Recent research has also found that acupuncture relieves pain because it changes the brain""s chemistry.
Today, there are several alternative forms of acupuncture being performed; the most popular ones are ear acupuncture, or auriculotherapy, acupressure, electrostimulation and moxibustion. Ear acupuncture is highly popular because the ear alone has 200 acupuncture points. Acupressure is the use of hands or a small, flat instrument to stimulate the acupuncture points.
Electrostimulation is the use of local electricity to stimulate acupuncture points, and moxibustion is the use of special herb to stimulate acupuncture points thermally. Depending on specific condition, an acupuncturist chooses the best treatment for the patient.
Electro-acupuncture refers to the procedure of applying small amounts of electricity to needles or staples applied to the skin at acupuncture points. In 1958 when the Chinese were developing methods of acupuncture for surgical anaesthesia, which necessitated long periods of manual manipulation, it was found to be more effective to stimulate the needles electrically by attaching flexible wires, via small crocodile clips, to the needles from a pulse generator. Electroacupuncture was reborn and later introduced into clinical practice on a more general basis for the treatment of pain and neurological disorders. Usually 4-8 needles can be stimulated at one time via parallel channels on the stimulator. One pair of needles inserted into two acupuncture points, wires and a pulse generator outlet is required to complete one circuit. Pulses of electricity are applied to the needles in order to stimulate nerves via the acupuncture point.
U.S. Pat. No. 6,122,547 issued in 2000 to Benja-Athon describes a consolidated electrical-lead acupuncture needle for electroacupuncture and is aimed at prevention of transmission of infectious organisms such as bacteria, virus, and fungus between patients and acupuncturists in electroacupuncture. It is stated in the aforementioned patent that transmission of infections and diseases in electroacupuncture between patients and acupuncturists is well documented in the scientific literature (Ernst E. et al. Life-threatening adverse reactions after acupuncture? A systematic review. Pain 71: 123-126, 1997). Two of the reasons are that there is a lack of sterile equipment and technique and the disregards for using sterile equipment and technique. The design deficiency of the prior art of acupuncture pin and equipment significantly contributed to aforementioned problems.
Presently, electroacupuncture uses the micron-thick shaft of a metallic needle grasped by a relatively larger alligator clip. Alligator clip is attached to one end of an electrical lead, which, in its turn, is attached to the electrical machine. The electrical lead of prior art consists of a plastic-insulated wire with one end connected to a grasping device such as a crocodile clip and the opposite end connected to the electrical stimulator. To establish the flow of electrical current from the electrical lead to the shaft of the acupuncture needle, the crocodile clip grasps onto the micron-thick shaft of the acupuncture needle for the purpose of transmitting electrical current from the stimulator via the wire, the grasping device, and the acupuncture needle, into the patient.
Among other things, it is stated in the aforementioned patent that the connection between crocodile clip and the micron-thick shaft of the acupuncture needle is loose and poor. The crocodile clip is not designed for the purpose of grasping the micron-thin shaft of the acupuncture needle whose diameter is too small to be effectively grasped by the crocodile clip. As a result, unreliable delivery of correct ampere and voltage of the electrical current to the acupuncture needle is common. Second, the contact parts of the crocodile clip, after so many uses, are often oxidized rendering the clip ineffective due to a barrier of a layer of nonconductive oxidized matters.
Breaching of the sterile technique is common. First, the crocodile clip and the electrical lead, which are not sterile to start, will not fix to one position site of the shaft of the acupuncture needle and will slide toward the acupuncture site of the skin during the application of the electrical lead leading to the contamination of the acupuncture skin site and, consequently, the transmission of infectious organisms via the acupuncture site of the skin. Second, the electrical lead and the crocodile clip are reused from patient to patient. Even though the acupuncture needle is sterile, the crocodile clip and its electrical lead are not sterile.
Heavy crocodile clip tends to swing loosely in the air without a means of attaching to the skin, consequently, causing the weight of the electrical lead to easily dislodge the percutaneously implanted acupuncture needle and exposing the sharp tip of the acupuncture needle to inadvertently puncture the fingers of the acupuncturists resulting in the transmission of diseases in electroacupuncture.
The acupuncture needle and, therefore, the sharp tip of the shaft are difficult to visualize, especially in the clinical settings and, consequently, inadvertent puncture of the fingers of the acupuncturists is common leading to the transmission of diseases in electroacupuncture.
It is offered, in the aforementioned patent, to solve the problems described in connection with the conventional electro-acupuncture needles and connections of the needles to the conductive wires by utilizing an integrated electrical-lead acupuncture needle comprising 1) a first electrical lead member as the first physical continuation of a second electricity-conducting shaft member wherefore adaptable to variably adjust and change the length of said shaft member, 2) a rigid or semi-rigid plastic cannular handle member comprises a bore and a first bevelled opening at the first bevelled end for the passage of said shaft member and incrementally and successively the entire said shaft member, and a second square opening at the end of said bore for the passage of said shaft member and said electrical lead. One portion of said shaft member is housed and fits in the bore and the other portion of said shaft member is beyond said bevelled opening of the cannular handle member. The length of the [first] shaft member within said bore is dictated by the length of said handle member but the [second] shaft member beyond said bevelled opening can be variably changed and adjusted by incrementally extending from and retracting into said bore by pushing and pulling, respectively, said electrical lead so that in the latter setting the entire length including the tapered sharp tip of said shaft member can be housed in and sheathed within said bore of said handle member. The electrical lead comprises a first enlarged and fixed spiral stopper portion to encumber the electrical lead beyond the bore of the handle. The second shaft member comprises a second enlarged and fixed spiral stopper portion to encumber second electricity-conducting shaft member beyond the bore of the handle. The third stopper is the second square opening of the handle member. The device includes adhesive on the handle for reversibly affixing the unit to the skin of human. Aforementioned features compel the acupuncturist to discard said unit after one single use on a patient.
Unfortunately, while addressing safety issues, the aforementioned patent offers little help to solve problems related to the weight and, hence, to the mechanical torque which the electrical lead member and the connection means apply to the needle. This torque makes the inserted portion of the needle shift inside the punctured tissues. It causes pain, discomfort, and can sometimes pull the shallowly inserted needle out completely. Furthermore, the usage of the device of the aforementioned patent is limited to xe2x80x9ceither monopolar pin, monopolar needle, concentric needle electrode or concentric pin electrodexe2x80x9d. Typical modern acupuncture needle has a shaft and a bigger handle.
It is an object of the present invention to provide an electroacupuncture device which is simple in construction, convenient in use, simplifies the electroacupuncture procedure, prevents transmission of infectious organisms such as bacteria, virus, and fungus between patients and acupuncturists in electroacupuncture, does not use heavy alligator clips for electrical contact between the electrical pulse generator and the needle, improves reliability of the aforementioned electrical contact, prevents oxidation of the contact parts, and makes it possible to significantly reduce the weight of current transfer parts connected to the needle.
The device according to the invention comprises specially designed electrodes and lead wires for use in electroacupuncture procedure that supply electric pulses to the patient""s skin via acupuncture needles. The device is intended for use with a standard electric pulse generator for electro-acupuncture procedure. The electrode consists of a fin made of a thin metal plate or foil that possesses electroconductive properties, has a substantially rectangular or triangular shape, and possesses rigidity in the direction of the acupuncture needle. The corners of the rectangular or triangular electrode can be rounded in order to prevent scratching of the patient""s skin. The plate-like electrode has a hole on one edge for connection of a lead wire from the electric pulse generator and a thickened portion on the other edge with a blind hole for fitting the electrode onto the handle of the acupuncture needle. On the side opposite to the insertion of the acupuncture needle, this hole can be closed by a cap that can be conveniently used for pushing on the needle for inserting the needle tip into the patient""s skin. In order to protect the wire-contact hole from rupture by the lead wire, the wire-contact hole can be reinforced. The depth of the opening for a needle is equal or slightly grater than the length of the handle of the needle in order to prevent physical contact between the lower edge of the fin and the skin of the patients when the electrode is placed on the pre-inserted needle. The fin should have dimensions convenient for grasping with the practitioner""s fingers. The lead wire is very thin and light, and preferably is made of copper. One end of the lead wire is exposed and has a hook-like shape for insertion into and engagement with the reinforced hole in the edge of the fin, while on the opposite end the wire may have a standard adaptor for connection to the electric pulse generator. According to another embodiment, the electrode is formed by wrapping a piece of metal foil, having a preformed hole for connection to the lead wire, around the needle handle leaving the tip of the needle projecting outside from the wrapped portion and leaving the hole exposed in an unwrapped portion.